FDA Orange Book
Generic for Beyaz
Beyaz contains drospirenone, ethinyl estradiol and levomefolate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Beyaz is drospirenone, ethinyl estradiol and levomefolate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Beyaz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | Marketed (Rx) | AB | 2 | AB |
NDA 022532, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic drospirenone, ethinyl estradiol and levomefolate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 203593 | AB (A-rated, therapeutically equivalent) | October 11, 2016 | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG |
| LUPIN LTD | 205947 | AB (A-rated, therapeutically equivalent) | June 13, 2018 | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG |
Beyaz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8617597 | February 8, 2030 | Drug product | None | 022532 |
| 11617751 | July 17, 2030 | Drug product | U-1 | 022532 |
| 11617751 | July 17, 2030 | Drug product | U-3572 | 022532 |
| 11617751 | July 17, 2030 | Drug product | U-3573 | 022532 |
| 11617751 | July 17, 2030 | Drug product | U-3574 | 022532 |
Questions
Is there a generic for Beyaz?
Yes. The generic name for Beyaz is drospirenone, ethinyl estradiol and levomefolate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Beyaz?
The active ingredient in Beyaz is drospirenone, ethinyl estradiol and levomefolate, per the FDA Orange Book.
When does the Beyaz patent expire?
The last patent listed for Beyaz in the Orange Book expires July 17, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.